China-based Hansoh Pharmaceutical has achieved two consecutive Phase III wins for risvutatug rezetecan, a B7-H3–targeted antibody–drug conjugate (ADC), after the ARTEMIS-008 trial in second-line small cell lung cancer (SCLC) met the overall survival (OS) primary endpoint, and the ARTEMIS-011 trial in osteosarcoma met the independent review committee-assessed progression-free survival (PFS) primary endpoint.

Risvutatug rezetecan is the first B7-H3 ADC to demonstrate significant OS benefit in a Phase III study and the only one to post positive Phase III results across two distinct tumour types, becoming the B7-H3 ADC in global development with the strongest evidence. Registrational Phase III programmes are also underway in non-small cell lung cancer (NSCLC), oesophageal squamous cell carcinoma, and osteosarcoma, with proof-of-concept studies advancing in head and neck, prostate, and colorectal cancers.

Partner GSK, which secured ex-China rights in late 2023, is accelerating global development with a first global Phase III readout expected in 2027, three additional global Phase III starts in the second half of 2026 covering first-line small cell lung cancer (SCLC) and front-line or post-line castration-resistant prostate cancer (CRPC), and proof-of-concept extensions into pancreatic, bladder, and gastric cancers thereafter.

GSK's recent USD 10.6 billion acquisition of Nuvalent further signals strategic intent to build a lung-cancer franchise around this asset. For Hansoh, risvutatug rezetecan represents a second-generation growth engine beyond the third-generation EGFR-TKI almonertinib, demonstrating Chinese-origin pipeline assets can lead global target validation, multi-region clinical execution, and multinational co-commercialisation.